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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K930229
Device Name CLINICAL NEURO SYSTEMS CRANIAL DRILL
Applicant
Clinical Neuro Systems, LLC
875 Norma Way
Santa Barbara,  CA  93111
Applicant Contact STEPHEN W LAGUETTE
Correspondent
Clinical Neuro Systems, LLC
875 Norma Way
Santa Barbara,  CA  93111
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number882.4310
Classification Product Code
HBE  
Date Received01/19/1993
Decision Date 03/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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